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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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EMA Reports Rise in Pharmacovigilance Inspections in 2016

Posted 08 August 2017 | By Michael Mezher

In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs.

Background

In the EU, routine pharmacovigilance inspections are typically carried out by national regulators to check that marketing authorization holders have the personnel, systems and facilities in place to perform required pharmacovigilance activities.

EMA's Committee for Medicinal Products for Human Use (CHMP) can also initiate requests for pharmacovigilance inspections in certain situations, including "for cause" inspections or to inspect a global pharmacovigilance site.

Rise in Inspections

The overall increase stems from a high number of inspections carried out by national inspection programs, with 49 for the year, compared to 36 in 2015 and 48 in 2014.

But EMA also said the number of pharmacovigilance inspections rose for all medicinal products in the EU, not just centrally authorized ones, when compared with the two previous years. In total, EMA said there were 217 pharmacovigilance inspections for human medicines and 80 for veterinary medicines in 2016. In 2015 there were 127 and 57, respectively, and in 2014 there were 167 and 35.

While the number of inspections rose overall in 2016 compared to the two previous years, the number of inspections requested by CHMP dropped significantly from ten in 2014 and seven in 2015 to only two in 2016, one of which was not initiated until 2017.

Of the two inspections requested by CHMP in 2016, neither was for a global pharmacovigilance site, though the agency requested one inspection of a global site in 2015 and three in 2014.

The number of deficiencies cited in inspections requested by CHMP also dropped compared to the two previous years, from 79 in 2014 to 70 in 2015 to 20 in 2016.

Of those, EMA says that two deficiencies were considered critical, three were major and 15 were minor, with the top three deficient areas having to do with adverse event reporting, quality management systems and computerized system issues.

Adverse event reporting and quality management system issues were also in the top three deficient areas in 2014 and 2015, though communications issues with national agencies and organizational structure replaced computerized system issues for the third most frequent deficiency in those years.